Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

NCT00723099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-12-27

Study results available
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Summary

This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.

Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Aggressive Non-Hodgkin Lymphoma
  • Chronic Myelogenous Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia
  • Indolent Non-Hodgkin Lymphoma
  • Lymphoma
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Follicular Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Plasma Cell Myeloma
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Chronic Myelogenous Leukemia
  • Refractory Follicular Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Small Lymphocytic Lymphoma
  • T-Cell Non-Hodgkin Lymphoma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo umbilical cord blood transplant

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given IV or PO

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo umbilical cord blood transplant

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Rachel Salit · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-25
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723099 on ClinicalTrials.gov